Senior Auditor, Quality Assurance
Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies because we are passionate to change lives. Discover what our 29,000 employees across 110 countries already know: WORK HERE MATTERS EVERYWHERE
Job responsibilities
General Profile
Syneos Health Audits
Plans and conducts assigned audits.
Performs For Cause audits.
Writes and issues audit reports, ensuring clear communication of audit findings to the auditees and relevant management.
Reviews responses to audit findings for appropriateness and completeness.
Closes assigned audits.
Customer Audits/Inspections
Prepares for and hosts or supports customer audits.
Prepares for and hosts or supports Regulatory Authority Inspections.
Other
Serves as Lead Auditor on team-based Syneos Health audits.
Serves as a trainer and mentor to less experienced QA auditors.
Supervision
Requires minimal instructions on day-to-day work and new assignments.
Other tasks
May write, review, or revise QA Standard Operating Procedures (SOPs) / Work Instructions (WIs).
Performs other work-related duties as assigned.
Moderate travel may be required (up to 50%).
Qualifications
What we're looking for
Requires a Bachelor's degree in the science/health care field or equivalent with extensive experience in GCP quality assurance auditing.
5-8 years of experience in the conduct of multiple audit types (e.g. vendors, investigator sites, trial master files, data management, safety reporting, and laboratories) in clinical trials.
Excellent Knowledge of GCP regulatory requirements.
Knowledge of Medical and technical terminology related to the audit types to be conducted.
Computer literacy commensurate with job requirements (Microsoft Office suite; basic SharePoint proficiency).
Able to handle multiple tasks to meet timelines in dynamic environment.
Strong organizational, presentation, and interpersonal skills.
Cultural sensitivity to allow effective communication with stakeholders from diverse cultural backgrounds.
Ability to negotiate, problem solve, and provide constructive feedback.
Well-developed communication skills and the ability to write concise, accurate reports and other necessary documentation.
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health
Additional Information : Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the
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